Agriculture Reference
In-Depth Information
3 and 4 as well as feeding studies are
necessary, because unregulated crops pro-
duced by other breeding methods also
undergo genetic changes and contain
unintended ef ects (Chassy, 2010). However,
it is possible that the process of genetic
modii cation could result in unintended,
potentially adverse pleiotropic changes
(Cellini et al ., 2004) that might not be
detected analytically (Delaney, 2007).
h erefore, feeding studies in laboratory and
target animals are considered necessary for
nutritional and safety assessment.
Kleter and Kok (2010) and Davies and
Kuiper (2011) consider the following aspects,
which also include nutritional aspects for
risk assessments:
 Characteristics of donor and recipient
organisms (see Chapter 2).
 Genetic modii cation and its functional
consequences (see Chapter 2).
 Potential environmental impacts (see
Chapter 3).
 Agronomic characteristics.
 Compositional and nutrit.ional char-
acteristics (see Chapter 4).
 Potential for toxicity and allergenicity of
genetic products, plant metabolites and
whole GM plants (see Chapters 3 and 4).
 Inl uence of processing on the properties
of feed (see Chapter 4).
 Potential for changes in dietary intake
(see Chapters 6 and 7).
 Potential for long-term and multi-
generational nutritional impact (see
Chapter 8).
feed and food. Unfortunately, there are
some feeding studies with high public
interest but with large weaknesses in the
i eld of clear characterization of feeds and
mixed feeds and experimental design (e.g.
Velimirow et al ., 2008; Seralini et al ., 2012).
Feeding studies with laboratory animals,
but much more with target animals, are key
elements for the nutritional and safety
assessment of feed/food from GM plants.
Depending on the scientii c questions, the
following types of feeding studies (see Table
5.1) are well established and may be carried
out:
 Laboratory animal models for the toxicity
testing of single substances (single-dose
toxicity testing; repeated-dose toxicity
testing; reproductive and developmental
toxicity testing; immunotoxicity testing,
etc.; OECD, 1998a; DBT, 2008; EFSA,
2008; Ladics et al ., 2010).
 Laboratory animal models for the safety
and nutritional assessment of whole GM
feed and food (in general 90-day feeding
studies for safety assessment) to detect
unintended ef ects, subchronic animal
tests, for margins of safety, etc. (OECD,
1998b; DBT, 2008; EFSA, 2011b).
 Studies to measure the digestibility/
bioavailability of nutrients from GM
plants and to analyse the inl uence of GM
products on the metabolism of target
animals/categories (ILSI, 2004, 2007;
Flachowsky and Böhme, 2005; DBT,
2008; EFSA, 2008).
 Tolerance studies to analyse the inl uence
of maximal amounts of GM feeds on
animal health and welfare (ILSI, 2007;
DBT, 2008; EFSA, 2008).
 Ei cacy studies to measure the inl uence
of GM feed on animal yield/performance,
feed conversion rate (FCR) and slaughter-
ing performance, as well as the safety and
composition/quality of food of animal
origin (ILSI, 2007; DBT, 2008; EFSA,
2008; see Chapters 6 and 7).
 Long-term studies to i nd out the long-
term ef ects of GM feed (e.g. whole
growing period in the case of growing
animals, whole laying period in the case
of laying animals, or one or more
5.2 Types of Feeding Studies
Before commencing feeding studies, com-
positional analysis (including nutrients and
undesirable substances) of all feeds used in
the study (see Chapter 4) and of mixed feed
given to experimental animals, as well
various in silico , in vitro or in sacco studies
(see ILSI, 2003, 2007; FSANS, 2007; DBT,
2008; EFSA, 2008, 2011a) are the key
elements of animal feeding studies and
contribute substantially to the nutritional
and safety assessment of GM plant-derived
 
 
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